Complying with Good Laboratory, Clinical, and Manufacturing Practices (GxP) guidelines is one of the biggest challenges facing Core Informatics’ customers. GxP guidelines make certain that pharmaceuticals and other products are safe and can be easily traced through the development and supply chain. “Our customers need to ensure their systems and applications are validated for GxP compliance,” says Richard Duffy, vice president of engineering at Core Informatics. “That can be a long process, with hundreds of hours just spent on the qualification process alone.”

In response to that challenge, Core Informatics wanted to build a standardized platform for deploying GxP-validated customer workloads. However, to scale to meet their customer demand, the company needed to ensure its platform was easy to deploy and manage. “We needed security to be simple to manage,” says Duffy. “With the hundreds of customer databases we have, we must simplify the process of managing security patches and conducting maintenance every few months. The number of resources and amount of time required to effectively support this is daunting.”

For many years, Core Informatics has used Amazon Web Services (AWS) to support its business applications for non-regulated customers. “We had a lot of success with AWS in terms of scalability and reliability,” says Duffy. Core Informatics then learned about the AWS GxP program, which provides guidance to enterprises with GxP requirements. “For our GxP customers, we still need to be as scalable and reliable as we’ve always been, but within a very restricted environment,” says Duffy. “AWS was the right choice for us when it came to creating a platform to run GxP workloads in the cloud.”

Core Informatics evolved the architecture for its Platform for Science to meet the needs of these regulated customers. “Using AWS, we were able to develop a platform that enables GxP-validated applications in the cloud for our customers,” says Duffy. Core Informatics uses Amazon Virtual Private Cloud (Amazon VPC) environments to provision specific sections of the AWS Cloud for its GxP-regulated customers. Within each Amazon VPC, Core Informatics employs AWS Elastic Beanstalk, a service for deploying and scaling web applications, along with Amazon Elastic Compute Cloud (Amazon EC2) instances on the Linux operating system. Amazon Relational Database Service (Amazon RDS) and Amazon Simple Storage Service (Amazon S3) are used to store customer data.

Additionally, the organization takes advantage of AWS CloudFormation templates to automate the provisioning of environments and create them in a standardized way to align with GxP requirements. Core Informatics relies on Amazon CloudWatch to monitor systems and gather metrics.

Core Informatics also enhances its security capabilities by using AWS. “Security is of utmost importance for our customers,” says Duffy. “From the client to the application to the infrastructure, a holistic approach must be taken to secure our customers’ data.” Core Informatics’ approach includes leveraging AWS services such as AWS Identity and Access Management (IAM), AWS Config, and AWS CloudTrail. “The use of AWS sub-accounts and IAM allows us to implement fine-grained control over our AWS assets to meet our security requirements,” says Duffy. “With AWS Config and AWS CloudTrail, we are able to control change and understand how and when changes are applied,” Duffy says. Amazon Inspector provides a means to conduct analysis of the deployed environment to proactively gauge potential threats.

Because security and compliance are critical for life sciences applications, and because Core Informatics demonstrated a strong commitment to its customers, the AWS Partner Network (APN) selected Core Informatics as a scientific data-management provider in the APN Life Sciences Competency.

Since agility and compliance are critical, AWS customers can: deploy validated applications in development and manufacturing, rapidly innovate and coordinate with remote partners, use data analytics to make decisions about geographic expansion, and efficiently leverage digital marketing resources to promote their brands.

With AWS, biotech and pharma companies can focus more on scientific discovery, clinical advancement, and sales instead of IT administration. For more information, visit our Life Sciences details page.

Core Informatics can now deploy GxP-regulated applications in the cloud for its life sciences customers. “Using AWS, we can prequalify and quickly deploy our Platform for Science solution and LIMS for customers needing to comply with GxP regulations,” says Duffy. “And we can use AWS tools to automate provisioning and record everything for validation purposes, so we remove many of the manual steps that could lead to inaccuracies.”

The company can also enable traceability, a key part of GxP compliance. “Any changes made to our application take place through AWS CloudFormation scripts, providing the traceability required for everything that happens in the environment,” Duffy says. Core Informatics customers are now more confident about having their product development data in the cloud, according to Duffy. “By giving our customers the ability to manage their GxP workloads on AWS, we are able to remove a lot of the initial fears they had about the cloud. The security capabilities and overall reliability of AWS provide the credibility our customers are looking for.”

In addition, Core Informatics’ customers can save money by using AWS. “For our customers, putting their regulated applications in the cloud costs about one-third what it would take to do it on premises,” says Duffy. “That’s critical for life sciences and pharmaceutical companies with tight budgets and fixed resources.”

Finally, by relying on Core Informatics’ cloud-based platform, the company’s customers gain more agility. “Our customers can move faster and complete drug discovery or next-generation sequencing projects more rapidly because the environment is now standardized,” says Duffy. “Using AWS, we can help organizations accelerate discovery while maintaining GxP compliance. It’s transforming our business and, more importantly, helping our customers transform their businesses.”